None listed
Conditions
Interventions
Drug : <
Investigastional Drug>
- Name : Naesohwajung-tang Ext. granules
- Component contents
Component herbs : Crataegii Fructus 2.50g, Hordei Fructus 2.50g, Magnoliae Cortex 1.88g, Auratii nobilis Pericarpium 1.88 g, Alismatis Rh
Placebo drug>
- Name : Pacebo of Naesohwajung-tang Ext. granules
- Component contents
Component herbs : None
Components : Lactose hydrate 3.268g, Cornstarch 3.080g, AF cacao color280 0.249g, Sepia color powder 0.
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals between the ages of 19 and 75 years old and literate in Korean 2) Individuals who meet the Rome IV diagnostic criteria 3) Individuals who have an average dyspeptic symptom score of over 40 points (on a 0-100 point visual analog scale, VAS) 4) Individuals who receive no other treatment during the study 5) Individuals who voluntarily agree to participate in the study protocol and sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Individuals diagnosed with a gastrointestinal disease confirmed by esophagogastroduodenoscopy within the last year (diseases include reflux esophagitis, erosive esophagitis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma, esophageal cancer, gastric cancer, disease of biliary tract or pancreas, and Helicobacter pylori-related gastritis) 2) Individuals who have obvious signs of irritable bowel syndrome 3) Individuals who have alarm symptoms (weight loss, black or tar stool, or dysphagia) 4) Individuals who have serious structural defects (heart, lung, liver or kidney disease) or mental illness 5) Individuals who have a history of surgery associated with the gastrointestinal tract excluding an appendectomy more than six months prior 6) Individuals who are pregnant or breastfeeding 7) Individuals who are taking medication that may affect the gastrointestinal tract (a minimum wash-out period of two weeks is required before participating in the trial) (medications include, NSAIDs, aspirin, prokinetic drugs, histamine-2 receptor antagonists, proton pump inhibitors, antidepressants, antibiotics, anti-ulcer drugs, absorbents, antiflatulents, digestive drugs, antidiarrheics, laxatives, antiemetics, emetics, anticholinergics, gastrin receptor antagonists, prostaglandin analogues, mucosal protective agents, steroids, and anticoagulants) 8) Individuals who participated in another clinical trial less than 30 days before the start of the current trial 9) Individuals who are HIV-positive 10) Individuals who are currently using traditional Korean medicine as treatment, including herbal medicine or drugs that may affect the dyspepsia 11) Individuals who are incapable of attending the clinical trial (due to paralysis, serious mental illness, dementia, drug addiction, limited time available to attend hospital appointments, severe visual or hearing impairments, illiteracy etc.) 12) Individuals diagnosed with clotting disorders, leukopenia, or seizure disorders, having a pace-maker, receiving anticoagulant therapy, abnormal electrocardiography, and blood and urine test results at screening i) Electrocardiography, Complete Blood Count (White Blood Cell, Hemoglobin, Hematocrit, Platelet), Liver Function Test (AST, ALT, rGT), Renal Function Test (BUN, Creatinine), ESR, Cholesterol (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, TG), Glucose, Routine Urine Analysis ii) criteria of abnormality - BUN, Creatinine >1.5 x upper limit of normal range - AST, ALT >1.5 x upper limit of normal range - Other results out of normal range with clinical dicision of principal investigator 13) Individuals who have uncontrolled chronic diseases despite appropriate managements (e.g., hypertension, diabetes mellitus) 14) Individuals who have been using of forbidden drugs less than 4 weeks before the start of the trial, excluding anti-hypertensive, hypoglycemic, and anti-hyperlipidemic treatment that might be considered not to affect the gastrointestinal tract and would be consistently used before or during the study 15) Individuals who show allergic response to NHT or placebo 16) Individuals who have symptoms and conditions that may affect the administration of the investigational drugs (e.g., dysphagia, clinically severe dyspepsia, galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption) 17) Individuals who have a history of alcohol abuse or drug dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Dyspepsia Symptom Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Treatment Effect;Single Dyspepsia Symptom Scale;Functional Dyspepsia-related Quality of Life;gastric myoelectrical activity measured by electrogastrography;Safety test (Blood test / Urine analysis);Food Retention Questionnaire;Damum Questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactNayeon Ha
Kyung Hee University Hospital
Outcome results
None listed